Study Results
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Basic Information
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COMPLETED
NA
280 participants
INTERVENTIONAL
2016-11-03
2020-04-29
Brief Summary
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Current written action plans must be short to be readily used (1 page) and, therefore, cannot fit all acute situations. Moreover, they may not be available where and when required.
The investigators sought that a digital action plan, available through Smartphone or tablet computer connected to the internet, could adequately provide suitable action plans according to the severity of the described exacerbation, and would be more easily available when useful.
The aim of the study is to study the effect of the use of a digital action plan for asthma exacerbation, on the frequency of unscheduled medical contacts (phone calls, visits to physicians or to emergency departments, hospitalizations) in children and in adults with asthma. The investigators hypothesized that the use of the digital action plan could reduce avoidable unscheduled visits due to mild or moderate exacerbations that could successfully be managed by the patient or his/her caregivers.
Detailed Description
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Reasons for medical contact may be related to the inefficiency of the current Written Action Plan because of its stereotyped advice whatever the level of severity of the exacerbation, and because the patients might not have the paper with him/her where and when he/she needs it.
The investigators sought that new electronic technologies could solve these issues of inadequacy of content and availability of the Written Action Plan.
A program was built to provide sets of advices according to the severity of the exacerbation described by the patient using simple clinical descriptors included in the Global Initiative for Asthma (GINA), and weighted by the medication already used for the exacerbation. In this way the investigators feel that patients could be more confident in the appropriate treatment proposed by the algorithm. Second, the possibility to connect through portable electronic devices (Smartphone, tablet computer) make the action readily available as far as an internet connection is possible.
The Digital Action Plan is designed to treat asthma exacerbations of all levels of severity and advice to visit a doctor within few days or to go at once to an emergency department as appropriate as by the situation based on the patients' information. The investigators designed a randomized study to assess the effect of the Digital Action Plan on unscheduled urgent medical contacts (phone calls, visits to physicians or to emergency departments, hospitalizations) in children and in adults with asthma.
Methodology of the study A multicenter, controlled, randomized, open study, comparative on 2 parallel groups recruited in private practice and in hospitals within or outside the APHP consortium.
Both arms have the Written Action Plan respecting the current recommendations; the experimental arm has in addition the possibility to connect to the AppWeb to obtain advices from the Digital Action Plan.
The investigators hypothesized that the use of the digital action plan could reduce avoidable unscheduled visits due to mild or moderate exacerbations that could successfully be managed by the patient or his/her caregivers. In the long run, this kind of program could also become a tool for telemedicine Statistical analysis : about 80% of children and adult patients included will have a exacerbation during the follow-up year. The expected effect of the Digital Action Plan is a 20% (relative variation) decrease of the main outcome : in Written Action Plan group, frequency = 0.8, in Digital Action Plan group, frequency = 0.64 (20% i.e. 0.16 reduction of frequency). Moreover, the Written Action Plan has been shown to result in a 25% decrease of unscheduled visits for severe exacerbation (4); we therefore hypothesize that the supplemental reduction in unscheduled visits induced by the Digital Action Plan will be smaller than that of Written Action Plan despite the recording of moderate exacerbations in addition to severe exacerbations. . With this features, samples of N= 121 per group are necessary (80% power, bilateral alpha risk of 5%). With an expected attrition of about 15%, a total of 280 patients will be included. This target can be achieved with regard to the activity of participating centers.
Number of participating centers = 43
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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1: Written action plan
Written action plan
Written action plan
2: Digital action plan
Written action plan + Digital action plan for asthma exacerbations Digital action plan for asthma exacerbation available through an AppWeb and requiring a connected device such as a Smartphone or a tablet computer. The patient must connect and describe the situation to obtain the names, doses and dosing of the treatment his/her physician has recommended for him/her according to the level of severity of the exacerbation
Digital action plan for asthma exacerbations + Written action plan
Digital action plan for asthma exacerbation available through an AppWeb and requiring a connected device such as a Smartphone or a tablet computer. The patient must connect and describe the situation to obtain the names, doses and dosing of the treatment his/her physician has recommended for him/her according to the level of severity of the exacerbation
Interventions
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Digital action plan for asthma exacerbations + Written action plan
Digital action plan for asthma exacerbation available through an AppWeb and requiring a connected device such as a Smartphone or a tablet computer. The patient must connect and describe the situation to obtain the names, doses and dosing of the treatment his/her physician has recommended for him/her according to the level of severity of the exacerbation
Written action plan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* typical asthma with medical diagnosis
* severe exacerbation (requiring ≥ 3 days of oral corticosteroids) during the previous 12 months
* Internet connexion through a private (patient's or parents' patient's if child) smartphone and/or a tablet computer
* no use of a written actin plan within the last 1 year
* agreement to have phone calls or email contacts during the 1 year follow-up of the study
* informed consent given, signed consent
* affiliation to a social security
Exclusion Criteria
* other respiratory disease (cystic fibrosis, COPD, etc.)
* Severe heart disease (except high blood pressure)
* smoking \> 15 pack-years
* asthma requiring regular oral corticosteroids treatment
* asthma requiring inhaled controller treatment administered via nebulizations performed at home
* no health insurance coverage
* sister or brother already included in this study (applies only to children)
* pregnancy and breastfeeding
6 Years
60 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Nicole BEYDON, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Privé Armand Brillard
Nogent-sur-Marne, , France
MulticEnter French study coordinate by AP-HP
Paris, , France
Countries
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References
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Beydon N, Taille C, Corvol H, Valcke J, Portal JJ, Plantier L, Mangiapan G, Perisson C, Aubertin G, Hadchouel A, Briend G, Guilleminault L, Neukirch C, Cros P, Appere de Vecchi C, Mahut B, Vicaut E, Delclaux C. Digital Action Plan (Web App) for Managing Asthma Exacerbations: Randomized Controlled Trial. J Med Internet Res. 2023 Jun 29;25:e41490. doi: 10.2196/41490.
Other Identifiers
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P140316
Identifier Type: -
Identifier Source: org_study_id